Senior Quality Assurance Specialist

1 month ago


Wuhan, Hubei, China CSL Full time
Job Title: Senior Specialist, QA System

Job Summary:

We are seeking a highly skilled Senior Specialist, QA System to join our team at CSL. As a key member of our Quality Assurance team, you will be responsible for maintaining our Quality Assurance System to ensure compliance with company and cGMP standards.

Responsibilities:

  • Maintain Quality Assurance System to ensure compliance with company and cGMP standards
  • Responsible for regulatory authority inspections and external customer audit management, including inspection preparation, establish inspection support team, CAPA response submission
  • Supplier audit and qualification management, including supplier performance review, approved supplier list & approved material list management, supplier audit schedule development and audit implementation, quality agreement management
  • Self-inspection management, including self-inspection plan development and implementation, follow up the execution of CAPAs to the observations in self-inspection
  • Manage the quality review of plasma center, including the on-site audit of critical materials in plasma center
  • CAPA management and eQMS management, oversight the whole CAPA process, monitoring the CAPA KPIs, make sure CAPA are managed in an efficiency way
  • Regulation monitoring, organize, coordinate, and supervise the gap analysis against new and revised GMP regulations, ensure the implementation of the identified measures
  • Product Quality Reviews (PQR) & Drug Annual Report management
  • Ensures standard operating procedures (SOP's) stay current and align with corporate and regulatory requirements
  • Executes training/awareness related to GMP standards

Qualifications:

  • University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
  • 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
  • Knowledge of current Good Manufacturing Practices (cGMP) principles

Our Benefits:

We encourage you to make your well-being a priority. It's important and so are you.



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